This study is a Phase IIa clinical trial initiated by the researchers, which is prospective, single-center, randomized, open-label, with blinded endpoint evaluation (PROBE design). Patients were screened through the emergency stroke green channel and included if they had an onset within 9 hours, met the criteria for large artery atherosclerosis (LAA) after multimodal imaging screening, received intravenous thrombolysis, and signed informed consent to participate. The study used block randomization (block size of 4), stratified by baseline National Institutes of Health Stroke Scale (NIHSS) score (5-10 vs \>10-20) and onset-to-thrombolysis time (\<4.5 hours vs 4.5-9 hours). Intervention group: received subcutaneous injections of Ilyumumab 420 mg (three syringes) within 24 hours after thrombolysis plus standard drug therapy (including statins). Control group: received conventional statin therapy (atorvastatin 20 mg/day) after thrombolysis. All patients received standardized stroke treatment (initiating antiplatelet therapy 24 hours after thrombolysis) and standardized management of blood pressure and blood glucose. NIHSS scores were assessed every 12 hours within 72 hours post-thrombolysis, and then daily thereafter, to evaluate the effectiveness of combined therapy in reducing early neurological deterioration (END). Blinding: The study is open-label. An independent Clinical Endpoint Committee (CEC) was established, and all clinical endpoint events (END assessment, 90-day mRS scores) were evaluated in a blinded manner by experts who were completely unaware of group assignments.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
132
Administer 420 mg (three vials) of evolocumab subcutaneously within 24 hours after thrombolysis.
Department of Neurology
Xuzhou, Jiangsu, China
RECRUITINGEarly deterioration of neurological function (END)
Defined as an increase of ≥2 points in NIHSS score or death within 1-7 days after thrombolysis. NIHSS scores should be assessed daily.The NIHSS (National Institutes of Health Stroke Scale) has a total score of 0 to 42. The higher the total score, the more severe the neurological deficit caused by stroke.
Time frame: within 1-7 days after thrombolysis.
Therapeutic efficacy
90-day functional prognosis (mRS 0-2 score rate and ordered shift analysis).The Modified Rankin Scale (MRS) is a core tool for assessing the degree of neurological function recovery in patients with stroke or other neurological disorders. The score ranges from 0 to 6, with higher scores indicating a more severe degree of disability.
Time frame: Within 90 days after thrombolysis
Mechanism exploration
Dynamic changes in serum PCSK9 levels from baseline to 36 hours and 72 hours after thrombolysis,and the correlation between these changes and the end of the treatment period.
Time frame: from baseline to 36 hours and 72 hours after thrombolysis.
Mechanism Exploration
Dynamic changes in serum hsCRP levels from baseline to 36 hours and 72 hours after thrombolysis,and the correlation between these changes and the end of the treatment period.
Time frame: from baseline to 36 hours and 72 hours after thrombolysis
Mechanism Exploration
Dynamic changes in serum IL-6 levels from baseline to 36 hours and 72 hours after thrombolysis,and the correlation between these changes and the end of the treatment period.
Time frame: from baseline to 36 hours and 72 hours after thrombolysis
Mechanism Exploration
Dynamic changes in serum NSE and S100β levels from baseline to 36 hours and 72 hours after thrombolysis, and the correlation between these changes and the end of the treatment period.
Time frame: from baseline to 36 hours and 72 hours after thrombolysis
Preset subgroup analysis
The impact of onset to thrombolysis time (\<4.5h vs 4.5-9h) on the primary efficacy endpoint.The efficacy therapeutic endpoint was early deterioration of neurological function (END).Defined as an increase of ≥2 points in NIHSS score or death within 1-7 days after thrombolysis. NIHSS scores should be assessed daily.The NIHSS (National Institutes of Health Stroke Scale) has a total score of 0 to 42. The higher the total score, the more severe the neurological deficit caused by stroke.
Time frame: within 1-7 days after thrombolysis
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